Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
Running, not enrolling · Phase 3
Conditions studied: Type 1 Diabetes Mellitus
In brief
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.
Key facts
- Study ID
- NCT00679042
- Run by
- CellTrans Inc.
- People needed
- 21
- Starts
- 2007-09-05
- Expected to finish
- 2026-06-14
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:
- At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level <50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
- Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of <54 mg/dL (3 mmol/l) as reported by the subject
You may not qualify if…
- Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)
- Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
- History of non-adherence to prescribed regimens
- Active infection including hepatitis C, hepatitis B, HIV
- TB by history, current infection, or under treatment for suspected TB
- History of malignancies except squamous or basal skin cancer
- Family history of MEN2 or MCT
- Stroke within the past 6 months
- BMI >27 kg/m2
- C-peptide response to glucagon stimulation, any C-peptide >0.3 ng/mL
- Inability to provide informed consent
- Age less than 18 or greater than 75 years
- Creatinine clearance <80 mL/min/1.73 m2 by 24-hour urine collection
- Serum creatinine consistently >1.5 mg/dL
- Macroalbuminuria >300 mg/24h
- Baseline Hb <12 gm/dL in women, <13 gm/dL in men
- Baseline liver function tests outside normal range
- Untreated proliferative retinopathy
- Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast feeding
- Previous transplant or PRA reactivity >80%
- Insulin requirement >0.7 IU/kg/day
- HbA1c >12%
- Hyperlipidemia (fasting cholesterol >130 mg/dL or fasting triglycerides >200 mg/dL
- Medical condition requiring chronic use of steroids
Where it is running
- University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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